Feasibility of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III-IV ovarian cancer: the ULTRA-LAP trial pilot study.

Laparoscopic Debulking Minimally Invasive Debulking Surgery Ovarian Cancer Visceral-Peritoneal Debulking

Journal

Journal of gynecologic oncology
ISSN: 2005-0399
Titre abrégé: J Gynecol Oncol
Pays: Korea (South)
ID NLM: 101483150

Informations de publication

Date de publication:
Mar 2024
Historique:
received: 01 04 2023
revised: 10 09 2023
accepted: 03 10 2023
pubmed: 3 11 2023
medline: 3 11 2023
entrez: 3 11 2023
Statut: ppublish

Résumé

A non-randomized prospective clinical trial (ULTRA-LAP) was registered to test safety, side effects and efficacy of laparoscopic Visceral-Peritoneal Debulking (L-VPD) in patients with stage III-IV ovarian cancer (OC). A pilot study was designed to identify which OC patients are suitable to undergo L-VPD. Between March 2016 and October 2021, all consecutive patients with OC underwent exploratory laparoscopy (EXL). All patients whose disease was deemed amenable for a complete resection (CR) at imaging review and EXL, underwent VPD. In all patients a consistent attempt was made at completing L-VPD. Two hundred and eight OC had EXL in the study period: 121 underwent interval VPD and 87 up-front VPD. Overall, 158 patients had VPD by laparotomy (75.9%) and 50 (24.1%) had L-VPD, of which 34 patients as interval (iL-VPD) and 16 as up-front (uL-VPD). Intra- and post-operative morbidity was very low in the L-VPD group. CR rate was 98% in L-VPD group and 94% in VPD. Most common reason for conversion was diaphragmatic disease extending dorsally. In the pilot study of ULTRA-LAP, L-VPD was completed in 24,1% of OC. Initial analysis supports the feasibility of L-VPD in 2 groups of OC: those with no gross disease at interval surgery and those with gross visible disease at upfront or interval surgery, but limited to: pelvis (including recto-sigmoid), gastro colic omentum, peritoneum and diaphragm, the latter not requiring dorsal liver mobilization. Both groups had 100% feasibility and have been thus forth recruited to ULTRA-LAP. ClinicalTrials.gov Identifier: NCT05862740.

Identifiants

pubmed: 37921599
pii: 35.e14
doi: 10.3802/jgo.2024.35.e14
doi:

Banques de données

ClinicalTrials.gov
['NCT05862740']

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e14

Informations de copyright

© 2024. Asian Society of Gynecologic Oncology, Korean Society of Gynecologic Oncology, and Japan Society of Gynecologic Oncology.

Déclaration de conflit d'intérêts

No potential conflict of interest relevant to this article was reported.

Auteurs

Roberto Tozzi (R)

Division of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy. roberto.tozzi@unipd.it.

Marco Noventa (M)

Division of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy.

Carlo Saccardi (C)

Division of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy.

Giulia Spagnol (G)

Division of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy.

Orazio De Tommasi (O)

Division of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy.

Davide Coldebella (D)

Division of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy.

Matteo Marchetti (M)

Division of Women's and Children Health, Department of Gynecology and Obstetrics, Padova University Hospital, Padova, Italy.

Classifications MeSH